Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A person:
(a) to whom a copy of a certificate, setting out the results of the examination and analysis of goods, is sent under subregulation 29(2); and
(b) who sends to the Secretary evidence in writing establishing that the goods do conform with the specified standard or comply with an applicable requirement, or, for medical devices, do comply with the applicable provisions of the essential principles or an applicable requirement;
may ask for the results of the analysis to be reviewed.
(2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the copy of the certificate.
(3) The Secretary must extend the period of 21 days if it is not reasonable to expect the person to provide the evidence within the period referred to in subregulation (2).
(4) A person is not to be regarded as having sent the Secretary evidence establishing that goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, unless that person has sent to the Secretary a certificate of a person (the third party ) who has appropriate qualifications and experience setting out:
(a) a statement that the third party has analysed a part of the same sample, or a similar sample from the same batch (if any), of those goods; and
(b) the results of that analysis; and
(c) details of the tests used in the analysis.
(5) If the certificate referred to in subregulation (4) shows that an analysis of goods for the purpose of establishing that the goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, was carried out in accordance with the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued, subregulation (6) applies to those goods.
(6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary must direct:
(a) if part of the sample remains unimpaired--an official analyst to send so much of the sample as remains unimpaired; or
(b) if no part of the sample remains unimpaired--that a further sample be taken by an authorised officer from the same batch as the original sample and that that further sample be sent;
to a person agreed (who may be an analyst or official analyst) upon by the person who requested the review and the official analyst referred to in subregulation (5), or, in the absence of agreement, to a person nominated (who may be an analyst or official analyst) by the Secretary.
(7) If a sample is sent to a person as mentioned in subregulation (6), the person is to:
(a) analyse the sample of the goods in accordance with the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued;
(b) send to the Secretary a certificate, signed by the person, setting out the results of the analysis; and
(c) send a copy of that certificate, signed by the person to the person who requested the review.
(8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7).
(9) If the findings of the responsible analyst are upheld, the sponsor must pay any charges payable to the person to whom a sample is sent as mentioned in subregulation (6) in respect of the analysis of the sample.
(10) In proceedings under the Act or these Regulations, a certificate issued under subregulation (7) or a copy of that certificate is, in the absence of evidence to the contrary, conclusive proof of the matters stated in it.
(11) A document purporting to be:
(a) a certificate of a person issued under subregulation (7); or
(b) a copy of that certificate, and purporting to be signed by the person;
is, in the absence of evidence to the contrary, to be regarded as the certificate or a copy of the certificate.